During an inspection of your firm located in Stuttgart, Germany, on December 10, 2007, through December 13, 2007, an Investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Astoflo Plus. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 32](h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.

Our inspection revealed that the Astoflo Plus is adulterated under section 501 (1)(1)(B) of
the Act, 21 U.S.C. 351(f)(1)(F3), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption IDE under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the Agency of your intent to introduce the device into commercial distribution, as required by section 51(7(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the Agency. 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is available through the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)). Also, U.S. federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taker. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.

Also, Stihler Electronics is distributing devices that are manufactured by WWT Technischer. Stihler Electronics needs to update the FDA listing records to reflect they are a distributor and not a manufacturer. In addition, your firm needs to create listings for two devices, the Astotherm IFT+ Astotube and the SpectraTherm, if these devices are exported to the United States.

If your firm is exporting the Prismaflo 11 to the United States, based on the information provided to the FDA Investigator, your firm will need to submit a new 510(k) to include the design changes for the Prismaflo II.

Your response should be sent to: Valerie A. Flournoy, Branch Chief, General Hospital Devices Branch, HFZ-333, 9200 Corporate Blvd, Rockville, MD 20850. If you have any questions about the content of this letter please contact: Valerie Flournoy at 240-2760 115 or FAX 204-276-0114.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.